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Protocol - Human Immunodeficiency Virus (HIV)

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Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

Description:

This protocol provides instructions for drawing, processing and storing blood for the human immunodeficiency virus (HIV) assay from the National Health and Nutrition Examination Survey (NHANES). Toolkit users are referred to the U.S. Food and Drug Administration's (FDA's) approved laboratory assays.

Protocol:

The following is a summary version of the full National Health and Nutrition Examination Survey (NHANES) 2007–2008 protocol.

Exclusion Criteria

Persons will be excluded from this component if they:

  • report that they have hemophilia; or
  • report that they have received cancer chemotherapy in the last 4 weeks

SP = Sample Person

1. Do you have hemophilia?

[ ] 1 Yes

[ ] 2 No

[ ] 7 Refused

[ ] 9 Don't Know

If the SP answers, "Yes," the SP is excluded from the blood draw.

If the SP answers "No" or "Don't Know," blood is drawn from the SP.

2. Have you received cancer chemotherapy in the past 4 weeks, or do you anticipate such therapy in the next 4 weeks?

[ ] 1 Yes

[ ] 2 No

[ ] 7 Refused

[ ] 9 Don't Know

If the SP answers, "Yes," the SP is excluded from the blood draw.

If the SP answers "No" or "Don't Know," blood is drawn from the SP.

Note from the Infectious Diseases and Immunity Working Group (WG): The investigator should record the reason a person is excluded from the blood draw.

Venipuncture Procedures

Editor's Note: Please review chapter 4 of the Laboratory Procedures Manual from the NHANES for a full description of Phlebotomy procedures: [alink[NHANES_Lab_manual.pdf|2007–2008 NHANES Lab Manual]]

Venipuncture should generally be performed using the median cubital, cephalic, or basilic vein in the left arm unless this arm is unsuitable. If the veins in the left arm are unsuitable, look for suitable veins on the right arm. If the veins in the antecubital space on both arms are not suitable, then look for veins in the forearm or dorsal side of the hand on the left arm/hand and then right arm/hand.

Recording the Results of the Venipuncture Procedure

Immediately after completing the venipuncture, record the results of the blood draw, the reasons for a tube not being drawn according to the protocol, and any comments about the venipuncture.

Note from the Infectious Diseases and Immunity WG: The Infectious Diseases and Immunity WG recommends that the investigator record whether the blood was drawn and whether the full amount was obtained.

Process the Sample for the Serum

Editor's Note: Please review chapter 8 of the Laboratory Procedures Manual from the NHANES 2007–2008 for a full description of Blood Processing procedures: [alink[NHANES_Lab_manual.pdf|2007–2008 NHANES Lab Manual]].

  • Allow the blood to clot by setting aside for 30-45 minutes at room temperature. Do not clot for more than 1 hour.
  • Centrifuge the tube at room temperature to separate the serum and aliquot into an appropriate storage tube.
  • Determine if the serum is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the plasma.

Laboratory Assay for Human Immunodeficiency Virus

There are now many laboratory assays that have been approved by the U.S. Food and Drug Administration (FDA). The Infectious Diseases and Immunity WG recommends that Toolkit users review the Centers for Disease Control and Prevention's (CDC's) November 2001 Morbidity and Mortality Weekly Report (MMWR) Issue 44 on HIV testing. Once an assay is chosen for a particular study, the WG recommends that consistent methods are followed so that assay results will be comparable.

The CDC MMWR for HIV testing provides the following FDA-Approved HIV Testing Procedures beginning on page 35: [alink[MMWR_CDC_AIDS.pdf|FDA-Approved HIV Testing Procedures]]

To aid comparability, the Infectious Diseases and Immunity WG recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.

Personnel and Training Required

Phlebotomist, and Laboratory that can perform the HIV assay

Equipment Needs

Phlebotomy supplies

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Health Professional

Life Stage:

Adult

Specific Instructions:

Research Domain Information

Release Date:

November 12, 2010

Definition

This is a bioassay to measure human immunodeficiency virus (HIV) antibodies.

Purpose

The measure determines whether a participant has human immunodeficiency virus (HIV) infection.

Selection Rationale

The National Health and Nutrition Examination Survey (NHANES) 2007-2008 protocol was selected as the best practice standardized methodology for blood collection, processing, and storage.

Language

English, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Antibody HIV Test Status2180464CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)HIV proto62882-6LOINC

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). (2007). National Health and Nutrition Examination Survey Questionnaire. Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). (2007). National Health and Nutrition Examination Survey Questionnaire. National Centers for Disease Control and Prevention Laboratory Procedures Manual for HIV Antibody/HIV Western Blot Confirmatory Test. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling, Testing, and Referral and Revised Recommendations for HIV Screening of Pregnant Women. MMWR 2001; 50 (No. RR-19).

General References

None

Protocol ID:

160901

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX160901_HemophiliaPX160901010000Do you have hemophilia? (exclusion from Phlebotomy)4Variable Mapping
PX160901_ChemotherapyPX160901020000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy)4N/A
PX160901_Exclusion_CriteriaPX160901030000Exclusion Criteria4N/A
PX160901_Blood_Draw_DonePX160901040000Was blood drawn?4Variable Mapping
PX160901_Blood_Draw_SamplePX160901040100Was full amount obtained?4Variable Mapping
PX160901_Blood_Draw_CommentsPX160901040200Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol.4Variable Mapping
PX160901_Sample_CommentsPX160901050000Record any comments about the sample during processing.4Variable Mapping
PX160901_HIV_Assay_TypePX160901060000Record the type of assay used for HIV testing.4N/A
PX160901_Equipment_MakePX160901070100Make of the equipment used to perform the HIV assay.4N/A
PX160901_Equipment_ManufacturerPX160901070200Manufacturer of the equipment used to perform the HIV assay.4N/A
PX160901_Assay_RepeatabilityPX160901080000Repeatability of the assay4N/A
PX160901_Coefficient_Of_VariationPX160901090000Coefficient of variation for the assay4N/A
PX160901_HIV_Assay_ResultsPX160901100000HIV assay results4N/A